VA Ann Arbor Healthcare System, Ann Arbor, MI, United States.
Department of Internal Medicine Division of General Medicine, University of Michigan, Ann Arbor, MI, United States.
J Med Internet Res. 2022 Feb 2;24(2):e31184. doi: 10.2196/31184.
Type 2 diabetes mellitus (T2DM) is a leading cause of morbidity and mortality globally, with adverse health consequences largely related to hyperglycemia. Despite clinical practice guideline recommendations, effective pharmacotherapy, and interventions to support patients and providers, up to 60% of patients diagnosed with T2DM are estimated to have hemoglobin A (HbA) levels above the recommended targets owing to multilevel barriers hindering optimal glycemic control.
The aim of this study is to compare changes in HbA levels among patients with suboptimally controlled T2DM who were offered the opportunity to use an intermittently viewed continuous glucose monitor and receive personalized low-carbohydrate nutrition counseling (<100 g/day) versus those who received usual care (UC).
This was a 12-month, pragmatic, randomized quality improvement program. All adult patients with T2DM who received primary care at a university-affiliated primary care clinic (N=1584) were randomized to either the UC or the enhanced care (EC) group. Within each program arm, we identified individuals with HbA >7.5% (58 mmol/mol) who were medically eligible for tighter glycemic control, and we defined these subgroups as UC-high risk (UC-HR) or EC-HR. UC-HR participants (n=197) received routine primary care. EC-HR participants (n=185) were invited to use an intermittently viewed continuous glucose monitor and receive low-carbohydrate nutrition counseling. The primary outcome was mean change in HbA levels from baseline to 12 months using an intention-to-treat difference-in-differences analysis comparing EC-HR with UC-HR groups. We conducted follow-up semistructured interviews to understand EC-HR participant experiences with the intervention.
HbA decreased by 0.41% (4.5 mmol/mol; P=.04) more from baseline to 12 months among participants in the EC-HR group than among those in UC-HR; however, only 61 (32.9%) of 185 EC-HR participants engaged in the program. Among the EC-HR participants who wore continuous glucose monitors (61/185, 32.9%), HbA was 1.1% lower at 12 months compared with baseline (P<.001). Interviews revealed themes related to EC-HR participants' program engagement and continuous glucose monitor use.
Among patients with suboptimally controlled T2DM, a combined approach that includes continuous glucose monitoring and low-carbohydrate nutrition counseling can improve glycemic control compared with the standard of care.
2 型糖尿病（T2DM）是全球发病率和死亡率的主要原因，其不良健康后果在很大程度上与高血糖有关。尽管有临床实践指南建议、有效的药物治疗以及支持患者和医务人员的干预措施，但多达 60%的 T2DM 患者的血红蛋白 A（HbA）水平估计高于推荐目标，这是由于多层面的障碍阻碍了最佳血糖控制。
本研究旨在比较接受间歇性查看连续血糖监测和接受个性化低碳水化合物营养咨询（<100 克/天）机会的血糖控制不佳的 T2DM 患者与接受常规护理（UC）的患者的 HbA 水平变化。
这是一项为期 12 个月的实用随机质量改进计划。所有在大学附属初级保健诊所接受初级保健的 T2DM 成年患者（N=1584）被随机分配到 UC 或增强护理（EC）组。在每个项目臂中，我们确定了 HbA>7.5%（58 mmol/mol）的有医疗资格接受更严格血糖控制的个体，并将这些亚组定义为 UC-高风险（UC-HR）或 EC-HR。UC-HR 参与者（n=197）接受常规初级保健。EC-HR 参与者（n=185）被邀请使用间歇性查看连续血糖监测仪并接受低碳水化合物营养咨询。主要结局是采用意向治疗差异-差异分析比较 EC-HR 与 UC-HR 组，从基线到 12 个月的 HbA 水平平均变化。我们进行了随访半结构化访谈，以了解 EC-HR 参与者对干预措施的体验。
与 UC-HR 组相比，EC-HR 组的 HbA 从基线到 12 个月时下降了 0.41%（4.5 mmol/mol；P=.04），但只有 61（32.9%）名 185 名 EC-HR 参与者参与了该计划。在接受连续血糖监测的 EC-HR 参与者中（185 名中的 61 名，32.9%），12 个月时的 HbA 比基线低 1.1%（P<.001）。访谈揭示了与 EC-HR 参与者计划参与和连续血糖监测仪使用相关的主题。
在血糖控制不佳的 T2DM 患者中，与标准护理相比，包括连续血糖监测和低碳水化合物营养咨询的联合方法可以改善血糖控制。
